Method for tissue expansion and regeneration using bioresorbable inflatable devices

ABSTRACT

Bioresorbable inflatable devices and tunnel incision tool and methods for treating and enlarging a tissue or an organ or a tube or a vessel or a cavity. The device is composed of a hollow expanding pouch made of a resorbable material that can be attached to a filling element. The pouch can be filled with a biocompatible materials, one or more times in few days interval, after the insertion of the device. While filling the pouch every few days the tissue expands and the filling material if it is bioactive start to function. The tunnel incision tool composed of a little blade that emerges from the surface of the tool in order to make shallow incisions in the surrounding tissue therefore enabling easy expansion of the tissue. This device and method can be used for example for: horizontal and vertical bone augmentation in the jaws and the tunnel incision tool is used to make shallow incisions in the periosteum when using the tunnel technique, sinus augmentation when the device is placed beneath the Schneiderian tissue, vessels widening if the pouch become a stent etc.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates to an improved methods and devices fortreating and healing a tissue deficiency in a living human or animalbody. The method and the device combine a mechanical action and abiological action.

For example, the present invention can be used for guided boneregeneration in the jaws as part of dental treatment with dentalimplants.

The present invention consists of an expansion device based on abioresorbable film and a method for tissue regeneration. In order toclarify the principles of the present invention the followingdescription will focus on two implementations: bone regeneration in thejaws preceding dental treatment with dental implants and widening abiological tube using a stent. The same principles are implemented forother tissues and other organs and other areas of the body.

Treatment of edentulous patients with osseointegrated fixtures made oftitanium is a well known procedure in the art. The procedure includesinstalling a fixture in the alveolar bone of an at least partiallyedentulous jaw. Usually several months are required for proper healingafter fixture installation.

After healing, an abutment is installed on the upper portion of thefixture. After several weeks, an artificial tooth may be mounted on theabutment and the procedure is complete.

Installation of implants requires sufficient alveolar bone, generallyabout 10 mm height and 6 mm width.

When a tooth is removed, the alveolar bone is gradually resorbed becauseof the absence of stimulus of ossification-inducing pressure from theteeth. As the resorption process advances, the size of the bone getsreduced, i.e. the bone on which the dental roots are positioned—thealveolar ridge start shrinking.

The absence of just one tooth can cause modifications throughout thedental arch and even prompt a possible softening (loss of insertion)which may cause the loss of other teeth. The absence of several teethaggravates the problem. Bone loss may finally modify the patient'sappearance and, depending on the loss, may make him incapable ofreceiving bridges, implants or even dentures.

It is then necessary to carry out several surgical operations toreconstruct the alveolar ridge of the maxilla or mandible.

Although these methods of surgical reconstruction have been successfullyperformed, this type of operation has had drawbacks. Certain methodshave involved opening the mucoperiosteal tissue along the entire lengthof the atrophic alveolar ridge and then placing a bone graft materialand a membrane on top of the graft and then suturing the delicatemucoperiosteal tissue back together to cover the membrane. The role ofthe membrane is to maintain the bone graft in its place and to preventthe mucoepithelium from growing into the graft and interfering with theprocess of bone regeneration. This surgical operation has had drawbackssuch as:

-   -   1. Tearing of the mucoperiosteal tissue.    -   2. Migration of the bone graft in spite of the membrane.    -   3. Exposure of the membrane leading to infection and failure of        the regeneration.    -   4. Necrosis of the mucoperiosteal tissue.    -   5. Insufficient enlargement of the alveolar ridge.    -   6. Obliteration of the buccal vestibule because of stretching of        the mucoperiosteal tissue, necessitating vestibuloplasity.    -   7. Only lateral augmentation can be achieved bat not vertical.    -   8. All the hazards of a relative big operation in the mouth:        bleeding, nerve damage, infection, pain etc.

Yet another technique involves creating an envelope or channelsubperiosteally and then inserting the bone graft material into thechannel. The bone graft can be enclosed in a resorbable casing. Thisprocedure which is a minor surgical procedure overcome the problems of arelative big surgical procedure as described in the prior art bat hasdrawbacks:

-   -   1. It is difficult with this technique to place accurately the        graft.    -   2. The surgeon is often unable to achieve the desired        reconstruction of the atrophied ridge without perforating or        stretching of the mucoperiosteum to the point that pressure        necrosis develops.    -   3. Insufficient enlargement of the alveolar ridge.

In order to overcome some of these drawbacks, another small surgicalprocedure is done before the performance of the procedures mentionedabove. In this procedure an expandable device is placed beneath theperiosteum through a small incision. This device made of silicon isgradually filled with a liquid through a cannula. While this expandabledevice expands tension is transferred to the periosteum leading toenlargement of the periosteum. When the periosteum reached the desireddimension the expandable device is taken out and a bone graft is placedas described above, but now there is no need to stretch themucoperiosteal tissue therefor reducing the complications.

This procedure has two significant drawbacks:

-   -   1. Two surgical procedures are needed. A small procedure for        insertion of the expandable device and a big procedure for        placing the bone graft and the membrane.    -   2. All the hazards of a relative big operation in the mouth.

Another procedure of bone augmentation preceding the placement of dentalimplants is called sinus lift technique or subantral augmentationtechnique. There are three basic methods to perform this augmentation ofthe maxillary sinus:

The sinus lift technique introduced by Dr. Tatum:

This procedure which is the most popular requires cutting a “trapdoor”in the lateral wall of the maxillary sinus and then lifting gently theSchneiderian membrane without tearing the membrane, then placing bonegraft materials beneath the lifted membrane, then covering the“trapdoor” with a membrane and suturing. This technique has somedrawbacks:

-   -   1. It is a relative big operation.    -   2. The technique is complicated.    -   3. The Schneiderian membrane can be easily torn resulting in        infection of the sinus and failure of the operation.    -   4. The bone graft material can migrate beneath the Schneiderian        membrane.

The sinus lift technique introduced by Dr. Summers:

This technique requires breaking the floor of the sinus afterpenetrating through the alveolar ridge beneath the sinus. The bone graftis pushed into the channel in the bone and therefore the Schneiderianmembrane is elevated. This procedure has advantage over the Tatum'stechnique that the procedure is simpler and the operation is smaller,bat has also drawbacks:

-   -   1. The amount of augmentation is limited.    -   2. The Schneiderian membrane can be torn without the awareness        of the surgeon resulting in filling the graft above the membrane        and failure of the procedure.    -   3. The bone graft material can migrate beneath the Schneiderian        membrane.

The sinus lift technique introduced by Dr. Jerusalmy (U.S. Pat. No.5,711,315):

This technique includes the steps of lifting the Schneiderian membranefrom the antral floor, perforating the membrane and placing graftmaterial between the Schneiderian membrane and the antral floor. Theadvantage of this technique is that no bone surgery is needed, bat hasdrawbacks leading for very limited use of this technique:

-   -   1. The technique is complicated.    -   2. There is an intentional tear of the membrane that can cause        infection and failure of procedure. (All the other techniques        are trying to preserve the integrity of the membrane.)    -   3. The technique requires special equipment and skill that are        not familiar to the surgeons involved in dental implantology.    -   4. The bone graft material can migrate beneath the Schneiderian        membrane.

The present invention is unique because it is the only method and devicecombining together a bioresorbable barrier a graft material and anexpansion device therefor avoids most of the foregoing drawbacks andpermits a more simplified and effective means for bone regeneration:

-   -   1. The amount of augmentation is almost not limited.    -   2. The procedure is very simple.    -   3. There is only one surgical procedure.    -   4. The surgical procedure can be very small.    -   5. No tearing of the mucoperiosteal tissue    -   6. No Necrosis of the mucoperiosteal tissue    -   7. The risk of membrane exposure is much smaller.    -   8. The hazards of a big operation are avoided.    -   9. No obliteration of the vestibulum.    -   10. No migration of the graft material.    -   11. When used in sinus lift the chance of tearing the        Schneiderian membrane is much smaller and even if the membrane        is torn it is fixed automatically.    -   12. Vertical augmentation can be achieved.

In certain medical treatment procedures, a type of endoprosthesis deviceknown as a stent is placed or implanted within a blood vessel fortreating various problems such as stenonses, strictures, or aneurysms inthe blood vessel. These devices are implanted within the vascular systemto reinforce collapsing, partially occluded, weakened or abnormallydilated sections of the blood vessel. Stents may also be implanted inthe ureter, urethra, bile duct, or any body vessel which has beennarrowed, weakened or in any of the other ways which requiresreinforcement.

A common approach for implanting stents in peripheral or coronaryarteries is to first open the constricted region of the vessel via apercutaneous transluminally inserted angioplasty balloon catheter. Theuninflated balloon at the tip of the catheter is advanced into thenarrowed portion of the vessel lumen. The balloon is inflated so as topush the stenotic plaque outward, thereby enlarging the luminaldiameter. Thereafter another catheter containing the stent is advancedto the region just enlarged by the balloon catheter and the stent isdeployed. The catheter is withdrawn leaving the stent within the vessel.

The concept of implanting transluminally placed coil spring stentswithin an artery is not new. In one experiment in 1969, six stents wereimplanted in arteries of dogs. Three stents were stainless steel coveredwith silicone rubber and the other three stents were bare stainlesssteel. All three silicone coated stents occluded within 24 hours whiletwo of the three bare stents remained open for thirty months. The stentswere deployed using a pusher catheter having the same outer diameter asthe stent.

In 1983, thermally expandable stents were reported, in which an alloywire was shaped at thigh temperature into a stent configuration. Laterit was straightened at room temperature into a configuration suitablefor transluminal placement. Once placed within the vessel the stent wasexposed to elevated temperatures to cause the alloy to return to itsinitial coil configuration. Canine studies of these stents, using thealloy nitinol, an alloy of nickel and titanium, demonstrated restenosisand intimal thickening 8 weeks following implant.

In 1984, self-expanding stents were described in which a device wasintroduced percutaneously after torsion reduction and was deployed byapplying a reverse torsion in-vivo. This type of device proved to becomplex and limited by a small expansion ration. Another self-expandingstent used stainless steel wire in a zig zag configuration whichresulted in incomplete vascular contact and only partial healing of thedevice. Yet another mechanical self-expanding stent was reported where awoven multifiliment stainless steel stent was deployed by a catheterwith a constricting outer sleeve. Once in place, the outer sleeve wasremoved allowing self-expansion of the spring stent against the vesselwall.

Thrombosis occurred in these early prototypes, especially when thevessel tapered, and at branch points and at low expansion ratios. Canineaortic implantation resulted in multiple areas of vessel-to-stentadhesion at 3 weeks following implant. The stent exhibited minimalthrombogenicity.

Balloon expandable stents were first reported as being constructed ofwoven stainless steel wire where the cross points were silver solderedto resist radial collapse. The stent was deployed unexpanded over aballoon catheter, and once in position the stent was expanded by theoutward force of the balloon. 8 of 11 stents implanted remained open for1 to 8 weeks. It has been observed that the amount of intimalhyperplasia to be inversely proportional to the initial vessel lumendiameter. In another version, silver soldering cross points werereplaced by the use of a stainless steel tube with rows of offset slotswhich became diamond shaped spaces. Although neointimal hyperplasia wasobserved, all stents remained open in rabbit aortas for 6 months.

Placement of a stent in a blood vessel is described in Lindemann et alU.S. Pat. No. 4,878,906 where a combination of sheath covered sleeve anda balloon catheter are used to locate and place the prosthesis. Norecognition is given to the problems just discussed herein.

A prosthesis system using an expandable insert is shown in Garza et alU.S. Pat. No. 4,665,918, which is typical of those devices which areimplanted without any express concern for the biocompatibility of thedevice being inserted. One can expect many of the foregoing problems andconcerns to be evidenced by this device.

One device which is shown in U.S. Pat. No. 4,768,507 to Fischell et aldescribes a coil spring stent on which an application of a carboncoating or a carbon coated polytetrafluoroethylene has been applied onthe surface of the coil spring. Fischell et al teaches that thethrombogenic potential of the device is reduced, through a passivemethodology, but does nothing to address the biological response to theimplant as a foreign body. Moreover, no suggestion is made of a way toinhibit neointimal hyperplasia, which inevitably follows ballooncatheter induced injury to arterial vessels.

Yasuda U.S. Pat. No. 4,994,298 employs plasma polymerization to form athin flexible coating on stents, teaching that improvedbiocompatibility, such as non-thrombogenicity and tissue or bloodcompatibility may be improved. Again this process is a passivemethodology as previously described.

Spring like stents have been inserted using a sheath or restrainingelement to keep the spring from expanding until It is in place. Otherform of stent uses a method of expanding the stent once it is in place,such as a balloon catheter, Kreamer U.S. Pat. No. 4,740,207 describesone version of the balloon catheter version. In this patent, asemi-rigid tube which has a smaller relaxed diameter which is expandedto a larger operating diameter which is maintained by a retaining ledgeon the Inside of the graft. Concern here, of course, is that the insidelocated ledge and other retaining means may inadvertently function tocause further blockage of the tube once it is installed. Kreamer statesthat the tube is held in place by friction between the outer peripheryof the graft and the inner periphery of the vessel to preventdisplacement of the grant once in place In the vessel. The obviousconcern is that the size must be precise or the tube will expand toomuch or too little, either damaging the vessel or escaping from thelocation for which it was intended.

A number of conventional stents in order to be easily expandable have arolled up cylinder construction. For example, U.S. Pat. No. 5,443,500 toSigwart discloses an intravascular stent intended for implantation in astenotic area or zone of obstruction of a blood vessel consisting of aflat sheet that is perforated to form a reticulated or lattice typestructure with undeformable links and made of malleable material. Thesheet is temporarily rolled up and locked in a spiral with a relativelysmall diameter on a deflated balloon mounted on the end of a catheterand is held in the rolled up state by a tie laced into overlappinglinks. Once the device is in place in the restricted area of the bloodvessel to be treated and after the tie is removed, the rolled sheet isexpanded to a desired diameter by inflating the balloon.

U.S. Pat. No. 5,423,885 to Williams discloses an expandable, ballooncatheter delivered intravascular stent having a plurality of protrusionson its outer surface for engaging the artery walls in which it isdisposed. The stent has a rolled up sheet construction, whereinapertures are formed in the stent body from the space vacated in thebody by the material forming the protrusions. When the stent is expandedby the balloon catheter, the protrusions engage both the apertures andthe artery walls to lock the stent into the expanded diameter.

U.S. Pat. No. 5,306,286 to Stack et al. discloses an expandable stenthaving a rolled up mesh construction. The stent can be reduced indiameter by a rolling motion while still having a cylindricalconfiguration on its outer surface for uniform engagement with a vesselwall. The rolled up, absorbable stent is mounted on either a ballooncatheter, a mechanically expandable catheter, or other suitable stentdelivery assembly. By expanding the distal balloon of the catheter ormechanically expandable distal end portion of the mechanicallyexpandable catheter, the stent is expanded so as to engage the vesselwall. The stent comprises bioabsorbable porous material that reduces thelikelihood of embolization and promotes tissue ingrowth in order toencapsulate the stent.

U.S. Pat. No. 5,192,307 to Wall discloses a stent-like prosthesis whichis formed of plastic or sheet metal and is expandable or contractiblefor placement. The stent may selectively be biased towards a closedposition and lockable in an open position or biased in an open positionand lockable in a closed position. In the former case, the stent is putinto place in its collapsed condition, then forcibly expanded by aballoon to the desired locked condition. In the latter case, the stentmay be held by a pin or the like in its collapsed condition, and the pinremoved to allow the stent to assume its open position. The lockingfunction is performed by one or more hooks formed into the wall whichengage complementary recesses formed in an opposing wall to mechanicallyinterlock the rolled up sheet forming the stent.

U.S. Pat. No. 5,441,515 to Khosravi et al. discloses an intravascularstent comprising a cylindrical sheet having overlapping edges thatinterlock. The edges having a series of protrusions and apertures thatinterlock and ratchet as the stent expands to an open position tosupport a section of arterial wall. The stent may be expanded by aballoon catheter or it may be self-expanding. A plurality of retainingmembers keep the stent open, and a buckle fastening member is used inone embodiment.

There are also stents that have also therapeutic action. Often thesecatheters include specialized attachments for providing differenttreatment modalities. For example, the following references disclosecatheters with attachments for administering a therapeutic agent andperforming balloon therapy:

U.S. Pat. No. 4,824,436 to Wolinsky discloses a multi-lumen catheterhaving opposed ring balloons positionable on opposite sides of a plaqueformation in a blood vessel. Inflation of the ring balloons define anisolated volume in the vessel about the plaque. Heparin is then injectedinto the volume between the ring to assist the body in repairing theplaque deposit. This patent also discloses a central balloon which canbe employed to rupture the plaque prior to inflation of the ringballoon.

U.S. Pat. No. 4,832,688 to Sagae et al. discloses a multi-lumen catheterhaving an occlusion balloon positionable distally of a tear in a vesselwall. Inflating the balloon occludes the vessel and isolates at thetear. A therapeutic agent, such as heparin or thrombin, injected fromthe catheter into the volume reduces the risk of thrombosis orrestenosis. The balloon is then deflated and moved adjacent the ruptureand reinflated to repair the ruptured wall by coagulation of bloodthereat.

U.S. Pat. No. 5,254,089 discloses a balloon catheter having an array ofconduits disposed within the outer wall of the balloon. The conduitsinclude apertures in the other wall for delivery of medications throughthe wall of the balloon into the body of a patient. This type of balloonis often referred to as a channeled balloon.

U.S. application Ser. No. 08/105,737 to Lennoxx et al., disclosescatheters having spaced balloons for treating aneurysms. The inflatedballoons define an isolated volume about the aneurysm. A port connects avacuum source to evacuate the volume and draw the aneurysmal wall towardits ordinary position. Inflating a third balloon with a heated fluid tocontact the aneurysmal wall effects the repair.

Therapeutic agent and balloon delivery systems must meet certaincriteria. That is, the cross-sectional dimension of the catheter must beminimized to enable transit through the vessel while also havingsufficient dimension to enable fluid flow to selectively inflate anddeflate the balloon, guidewires to pass therein, and therapeutic agentsto flow therethrough for delivery along the catheter. Catheters mustalso have sufficient internal rigidity to prevent collapse of the lumenswhile having sufficient flexibility for passage along vessels.

Stent delivery systems, as disclosed by the U.S. Pat. Nos. 5,158,548 and5,242,399 to Lau et al. And U.S. Pat. No. 5,108,416 to Ryan et al.patents, often include a catheter supporting a compacted stent fortransport in a vessel and an expansible device for expanding the stentradially to implant the stent in the vessel wall. After removal of thecatheter, the expanded stent keeps the vessels from closing.

The U.S. Pat. No. 4,690,684 to McGreevy et al. patent discloses a stentformed of biologically compatible material, such a frozen blood plasmaor the like. According to McGreevy et al., a stent of this type carriedby a catheter may be inserted into opposed ends of a ruptured vessel tosupport the separated vessel walls while the ends are bonded together.Once deployed, the heat from the bonding operation and the bodyeventually melt the stent and clear the vessel.

The U.S. Pat. No. 4,922,905 to Strecker, patent describes a stent anddelivery system. The stent is knitted from metal or plastic filamentsand has a tubular structure. The delivery system includes a ballooncatheter and a coaxial sheath. The catheter supports and carries thecompacted stent to a site within the body. The sheath covers the stentpreventing premature deployment and facilitating transit of the stentthrough passages in the body. Exposure of the stent by moving the sheathaxially with respect to the catheter and expansion of a balloon urgesthe stent into contact with the walls of the vessel. Deflation of theballoon frees it from the stent and enables withdrawal from the vesselof the delivery system.

In the U.S. Pat. No. 4,950,227 to Savin et al. patent a stent deliverysystem includes a catheter having an expansible distal portion, a stentcarried thereon in a contracted position for expansion thereby andsleeves that overlie the end portions of the stent. The sleeves protectthe vessel and the stent during transit without substantially inhibitingdeployment of the stent.

In accordance with the Anderson patent a stent delivery system includesa dissolvable material that impregnates a self-expanding stent in acompacted form. In one embodiment the removal of a sheath exposes thestent to body heat and liquids so that the material dissolves and thestent expands into a deployed position.

Stent delivery systems used in such procedures generally includecatheters with selectively expansible devices to deliver and expand acontracted “stent” or restraints that can be removed to allow aself-expanding stent to assure an enlarged or expanded configuration.Stents are known and have a variety of forms and applications. Forexample, stents serve as prostheses and graft carriers in percutaneousangioplasty. Stents used as an endoprothesis and graft carriers to whichthe present invention relates usually comprise radially expansibletubular structures for implant into the tissue surrounding vessels tomaintain their patency.

Like the previously described therapeutic agent and balloon therapysystems, stent delivery systems must conform to several importantcriteria. First, it is important to minimize the transverse dimension ofthe delivery system, so the stent must be capable of compaction againsta delivery device, such as a catheter. Second, the delivery system mustfacilitate the deployment of the stent once located in a vessel. Third,the stent delivery system must easily disengage from the stent after thestent is deployed. Fourth, the procedure for removing the deliverysystem from the body must be straightforward. Fifth, the delivery systemmust operate reliably.

It has been found that the administration of therapeutic agents with astent can reduce the risks of thrombosis or stenosis associated withstents. Stents administered along with seed cells, such as endothelialcells derived from adipose tissue, can accelerate the reformation of anafflicted area. Likewise, tears or other vessel damage associated withballoon angioplasty can be reduced by a deployed stent used incombination with a therapeutic agent.

When both therapeutic agent and stent therapies are required, aphysician generally (1) steers a guidewire to the treatment locus, (2)guides a catheter over the guidewire, (3) operates the catheter toprovide the first stage of treatment, (4) inserts an exchange guidewireto the guidewire, (5) withdraws the catheter, (6) guides a secondcatheter over the guidewire, and (7) operates the second catheter toprovide the second stage of treatment. After this, the physicianwithdraws the guidewire, if not previously removed, and the catheterfrom the body of the patient.

U.S. Pat. No. 5,439,446 to Barry a stent delivery system thatincorporates a drug delivery system in the catheter. This device permitsthe surgeon to use one catheter to deliver both the stent and thetherapeutic agent at a selected site in the patient's body.

Other references disclose the use of stents that release therapeuticagents associated with a deployed stent over time. For example U.S. Pat.No. 5,234,457 to Andersen commonly assigned as this invention disclosesstents impregnated with a gelatin that enables the release of the stent.It is suggested that the gelatin could entrain a therapeutic agent thatdispenses as the gelatin dissolves.

These references thus provide the ability to deliver stents andtherapeutic agents to an afflicted site within a patient's body and evenenables the dispersion of the therapeutic agent from the stent overtime. However, if additional therapeutic agent is needed at the siteanother catheter must be inserted to deliver the therapeutic agent or bygenerally introducing the additional therapeutic agent to the vesselsuch as by injection in the case of a blood vessel or by bathing theesophagus for example.

In some cases where a slow release of the therapeutic agent is desired,as by the release of a therapeutic agent entrained in a gelatin or otherhydrophilic or hydrophobic polymers on a stent. Once the therapeuticagent was delivered, replenishment required one of two procedures. Inone, a new stent was inserted to be adjacent the old stent. Sometimesthis reduced the effectiveness of the therapeutic agent, particularlywhen the area of treatment was displaced from the second stent. Analternative that overcame that problem was substituting a new stent forthe old stent. It is true that percutaneous transluminal procedures andother procedures involving the insertion of stents into the body haveimproved in recent years. Likewise the reduction in the size of theinstruments inserted into the patient reduces the risk of damage.However, it is still a fact that each insertion and extraction risksfurther damage to afflicted areas and damage to otherwise unaffectedareas through which the instruments pass and can add to patient trauma.Moreover, insertion and withdrawal of additional instruments in sequenceincreases the time of the physician, staff, and medical facility, andthe cost of multiple instruments. Thus, reducing the number ofinstruments and the overall size of the instruments necessarily insertedand withdrawn from a patient, the steps required by the processes, andthe overall size of each of the instruments is generally preferred.

U.S. Pat. No. 5,857,998 to Barry enables replenishment of a reservoir inthe stent with therapeutic materials.

None of the prior art is enabling the widening of the vessel withouttemporarily blocking the passage through the vessel.

None of the prior art enables gradually widening of the vessel over somedays therefor limiting the risk of rupture.

None of the prior art enables safely widening the vessel beyond thefinal desired diameter to compensate for future restenosis.

In none of the prior art the balloon is the stent

None of the prior art has all the other properties of an ideal stent batonly some of them.

The other ideal properties of a stent are:

-   -   1. The insertion of the stent is done in one phase. There is no        need for a first balloon to widen the constriction.    -   2. The stent is the balloon therefor no need of withdrawal of        the balloon.    -   3. The stent is biocompatible.    -   4. The stent is bioresorbable.    -   5. The amount of widening is determined and monitored while        doing the procedure, without concern for the precise size of the        stent being employed or the size of the vessel being treated or        repaired.    -   6. The stent can be used to close ruptures of the vessel.    -   7. The stent is well attached to the vessel's walls.    -   8. The stent has therapeutic material on its outer surface        facing the walls of the vessel.    -   9. The stent has therapeutic material on its inner surface        facing the lumen of the vessel.    -   10. The stent can release therapeutic materials from a        reservoir.    -   11. The reservoir can be replenished.    -   12. The stent can produce rapid endothelialization with the        least mount of intimal hyperplasia.    -   13. The stent is strongly attached to the vessel's walls        therefor the risk of embolization is small    -   14. The stent is easily inserted to the vessel therefore the        risk of damaging the vessel is minimized.    -   15. The stent can adapt itself to bent shape of a vessel and        furcations    -   16. The stent in which problems associated with restenosis,        thrombosis, infection calcification and/or fibrosis after        implantation may be avoided.    -   17. The procedure is simple and short.    -   18. The widening can be changed after the procedure is over.    -   19. The stent is mechanically strong and can resist crush.    -   20. The stent is flexible and compliant.    -   21. risk of embolization is small.

Therefore, it is an object of this invention to provide a method andapparatus that has some or all of these properties.

SUMMARY OF THE INVENTION

The present invention provides a method and device by which inserting abiocompatible material into the body and at same time mechanicallyenlarging the surrounding of the device. The biocompatible material canbe a bioactive material like a drug or inert material.

The device is made of a pouch that can be filled preferably through afilling element with the biocompatible material. The pouch is made fullyor partially of a bioresorbable material and it acts like a balloon thatexpands as it is filled with the biocompatible material.

The pouch is filled one or more times every few days till the desiredenlargement is reached. While the pouch expands it conducts tensileforces to the surrounding tissues which reacts in proliferation andenlargement. At the same time more biocompatible materials are added.After the desired enlargement is reached the filling element can be pullout if necessary. There is no need to take out the pouch because it ismade of bioresorbable materials. The end result is a new or enlargecompartment in the body filled with a biocompatible material.

The insertion of the device can be through a small incision to a tunnelso all the process is done with almost no surgery. Through this incisionthe tunnel incision tool can be inserted before the insertion of thedevice. The tunnel incision tool makes shallow incision in thesurrounding tissue of the tunnel. These incisions allow initialexpansion of the tissue and easy insertion of the device.

There are many possible implementations of the device and methoddepending on several factors:

1. The place the device is inserted into.

2. The filling material.

3. The shape of the pouch.

4. The kind of filling element that is in use.

5. The kind of material the pouch is made of.

The device and method can be therefore used for selective regenerationof more or less specialized tissues, for example, membranes demarcatingbody cavities and/or separating different tissues and organs from eachother, as well as, for selective regeneration of different tissueswithin the organs, or the organs themselves in relation to thesurrounding tissues or nerves. Examples of membranes are the periosteum,the membranes of the brain and the peritoneal membrane; while examplesof organs are the liver, the throat, the ventricle, the kidney, theheart and the pancreas. Also, muscle tissue tendons, fat tissue,vessels, ducts, and tubes should be possible to regenerate with thisdevice and method.

The device and method are particularly useful for plastic surgery,dental implantology and in cardiac surgery. In plastic surgery it can beused for soft tissue enlargement like lips and breasts and for facialbones enlargement. In dental implantology it can be used for horizontaland vertical augmentation of the alveolar ridge when the pouch is placedbeneath the periosteum and for sinus augmentation when the pouch isplaced beneath the Schneiderian membrane preceding the placement ofdental implants. In cardiac surgery it can be used as a bioresorbablestent for vessel widening.

Other objects and features of the present invention will become apparentin the following detailed description when taken in connection with theaccompanying drawings which disclose one embodiment of the invention. Itis to be understood that the drawings are designed for the purpose ofillustration only and are not intended as a definition of the limits ofthe invention.

Thus, according to the teachings of the present invention there isprovided, a method for expanding, stretching or displacing living tissuecomprising: (a) inserting into the tissue an inflatable element made atleast in part from bio-dissipative material; (b) introducing into theinflatable element a quantity of a biocompatible filling material so asto displace the tissue; and (c) leaving at least part of the inflatableelement in place for a period sufficient to allow the bio-dissipativematerial to disperse.

According to a further feature of the present invention, the introducingis performed in a plurality of stages separated by at least a number ofhours, each stage incrementally stretching the tissue.

According to a further feature of the present invention, thebiocompatible filling material includes a bio-active material.

According to a further feature of the present invention, thebiocompatible filling material includes material for promoting thegrowth of at least one type of tissue.

According to a further feature of the present invention, the inflatableelement is located beneath the Schneiderian membrane of the maxillarysinus or of the nose.

According to a further feature of the present invention, the insertingis performed such that the inflatable element is located substantiallyat a bone-soft tissue interface, the biocompatible filling materialincluding material for promoting the growth of bone such that,subsequent to dispersal of the inflatable element, the biocompatiblefilling material promotes extension of the bone beyond the initialbone-soft tissue interface.

According to a further feature of the present invention, the materialfor promoting the growth of bone includes at least one material selectedfrom the group made up of: an autograft, an allograft, a xenograft, analloplast, a cytokine, a hormone, a growth factor, a physiologicallyacceptable drug, a biological modifier, a protein, an antigen, a cellchemotaxis stimulator material, a material inducing osteogenesis, anosteoinduction material, and an osteoconduction material.

According to a further feature of the present invention, the inflatableelement includes a guided bone regeneration membrane located so as to beadjacent to the soft tissue.

According to a further feature of the present invention, the inflatableelement is configured to have a first region which exhibits a first meantime to dispersion and a second region which exhibits a second mean timeto dispersion longer than the first mean time to dispersion.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a stretchable material.

According to a further feature of the present invention, the inflatableelement is formed from more than one type of material.

According to a further feature of the present invention, the inflatableelement is configured to have a first portion with a first stiffness anda second portion with a second stiffness differing from the firststiffness.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a material which serves as aselective barrier configured to allow at least a first material totraverse the barrier while preventing passage of at least a secondmaterial.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a self-expanding material.

According to a further feature of the present invention, thebiocompatible filling material includes a self-expanding material.

According to a further feature of the present invention, the introducingis performed via a filling conduit partially inserted into the tissue.

According to a further feature of the present invention, the fillingconduit is formed at least partially from non-bio-dissipative material.

According to a further feature of the present invention, the fillingconduit includes a sealing means for sealing the filling conduit afterthe introducing of the biocompatible filling material.

According to a further feature of the present invention, disinfectingmaterial is introduced into the filling conduit after the introducing ofthe biocompatible filling material.

According to a further feature of the present invention, the fillingconduit is implemented as a bone implant.

According to a further feature of the present invention, the fillingconduit is formed with at least one fixation feature.

According to a further feature of the present invention, the introducingis by temporarily puncturing the inflatable element with a needleinserted through the tissue, the inflatable element being configured tobe self-sealing on removal of the needle.

According to a further feature of the present invention, prior toinserting the inflatable element, a tunnel is formed into the tissue forinsertion of the inflatable element.

According to a further feature of the present invention, prior toinserting the inflatable element, a plurality of shallow, elongatedincisions are formed in the tissue adjacent to the tunnel so as tofacilitate stretching of the tissue.

According to a further feature of the present invention, the shallowelongated incisions are formed manually by moving an elongated tool withat least one laterally projecting blade in a reciprocating motion withinthe tunnel.

According to a further feature of the present invention, the elongatedtool is configured to produce incisions of depth no greater than about 2mm.

According to a further feature of the present invention, the elongatedtool is configured to produce incisions of depth between about 0.1 mmand about 1 mm.

According to a further feature of the present invention, the inflatableelement is configured to apply outward force on a substantiallycylindrical living tissue without completely obstructing a flow pathwhich passes within the substantially cylindrical living tissue.

According to a further feature of the present invention, the inflatableelement is configured as a double-walled sleeve.

There is also provided according to the teachings of the presentinvention, a device for expanding, stretching or displacing livingtissue comprising: (a) an inflatable element for insertion into thetissue, the inflatable element being made at least in part frombio-dissipative material; and (b) means for introducing into theinflatable element a quantity of a biocompatible filling material so asto displace the tissue.

According to a further feature of the present invention, the inflatableelement is configured to have a first region which exhibits a first meantime to dispersion and a second region which exhibits a second mean timeto dispersion longer than the first mean time to dispersion.

According to a further feature of the present invention, the inflatableelement includes a guided bone regeneration membrane.

According to a further feature of the present invention, the inflatableelement is formed from a plurality of types of material.

According to a further feature of the present invention, the inflatableelement is configured to have a first portion with a first stiffness anda second portion with a second stiffness differing from the firststiffness.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a material which serves as aselective barrier configured to allow at least a first material totraverse the barrier while preventing passage of at least a secondmaterial.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a self-expanding material.

According to a further feature of the present invention, the inflatableelement is formed at least in part from a stretchable material.

According to a further feature of the present invention, the means forinflating includes a filling conduit configured for inserting into thetissue so as to be accessible from outside the tissue, the fillingconduit being formed with at least one fixation feature configured toallow fixation of the conduit relative to the tissue.

According to a further feature of the present invention, the fillingconduit is formed at least in part from non-bio-dissipative material.

According to a further feature of the present invention, the fillingconduit includes a sealing means.

According to a further feature of the present invention, the fillingconduit includes a chamber for receiving disinfectant material.

According to a further feature of the present invention, the fillingconduit is implemented as a bone implant.

According to a further feature of the present invention, the means forintroducing includes a hollow needle configured to pierce part of theinflatable element for filling, the inflatable element being configuredto reseal itself after withdrawal of the needle.

According to a further feature of the present invention, the inflatableelement is configured to apply outward force on a substantiallycylindrical living tissue without completely obstructing a flow pathwhich passes within the substantially cylindrical living tissue.

According to a further feature of the present invention, the inflatableelement is configured as a double-walled sleeve.

There is also provided according to the teachings of the presentinvention, an elongated tool for forming shallow elongated incisions inliving tissue adjacent to a tunnel formed through the tissue so as tofacilitate stretching of the tissue, the tool comprising: (a) a handle;(b) an elongated shaft associated with the handle, the elongated shafthaving a direction of elongation, a maximum transverse dimensionmeasured perpendicular to the direction of elongation and a lengthmeasured parallel to the direction of elongation, wherein the maximumtransverse dimension is at least about 3 mm and wherein the length is atleast five times the maximum transverse dimension; and (c) at least oneblade projecting from the elongated shaft and configured to formincisions of depth no greater than 2 mm in adjacent tissue when the toolis inserted within the tunnel and moved parallel to the direction ofelongation.

According to a further feature of the present invention, the length isat least about ten times the maximum transverse dimension.

According to a further feature of the present invention, the maximumtransverse dimension is between about 5 mm and about 10 mm.

According to a further feature of the present invention, the at leastone blade is configured to form incisions of depth between about 0.1 mmand about 1 mm.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings, wherein:

FIG. 1 is a side view illustrating the skull of a human being andindicating general areas in which the skull bone structure is oftenaugmented;

FIG. 2 is a perspective view illustrating the novel device used inaccordance with the invention to receive and contain bone augmentationmaterial. in this preferred embodiment the filling element is a cannula.

FIG. 3 is a perspective view illustrating the device of FIG. 2. After itwas filled with bone augmenting material.

FIG. 4 is a bottom view illustrating the device of FIG. 3.

FIG. 5 is a sectional view of the device of FIG. 2.

FIG. 6A is a perspective view illustrating a filling instrumentcontaining bone augmenting material.

FIG. 6B is a sectional view illustrating the filling instrument of FIG.6A connected to and filling the device of FIG. 2.

FIG. 7A is a side view illustrating the tunnel incision tool.

FIG. 7B is a top view illustrating the tunnel incision tool.

FIG. 8A is a front perspective view of a patient's mouth prepared forthe insertion of the device with incision on one side of the lower jaw.

FIG. 8B is a sectional view of the alveolar ridge of FIG. 8A.

FIG. 9 is a front perspective view of a patient's mouth while insertingthe tunnel incision tool into the subperiosteal tunnel.

FIG. 10 is a front perspective view of a patient's mouth while insertingthe pouch of the device subperiosteally using an insertion tool.

FIG. 11A is a front perspective view of a patient's mouth after theinsertion of the pouch of the device beneath the gums and suturing theincision and fixating the protruding cannula.

FIG. 11B is a sectional view of the alveolar ridge of FIG. 11A after theinsertion of the device.

FIG. 12A is a front perspective view of a patient's mouth several daysafter the insertion of the device. The filling instrument is connectedto the cannula and filling the pouch.

FIG. 12B is a sectional view of the alveolar ridge of FIG. 12A aftersome filling of the device.

FIG. 13A is a front perspective view of a patient's mouth at the end ofthe filling process and removal of the cannula.

FIG. 13B is a sectional view of the alveolar ridge of FIG. 13A at theend of the procedure.

FIG. 14 is a sectional view of the maxillary sinus.

FIG. 15 is a perspective view illustrating the novel device used inaccordance with the invention to receive and contain bone augmentationmaterial. In this preferred embodiment the filling element is a hollowbone implant.

FIG. 16 is a sectional view of the device of FIG. 15.

FIG. 17 is a schematic illustration of drilling to reach the floor ofthe sinus.

FIG. 18 is a schematic illustration of breaking the floor of the sinususing an osteom.

FIG. 19 is a sectional view of the sinus after placement of the deviceof FIG. 15 beneath the Schneiderian membrane.

FIG. 20A is a sectional view illustrating a filling syringe filled withbone augmenting material for filling the device in sinus lift procedure.The syringe is composed of two parts.

FIG. 20B is sectional view illustrating the filling syringe of FIG. 20Aconnected to and filling the device of FIG. 15.

FIG. 21 is a sectional view of the sinus after filling the pouch of thedevice of FIG. 15 with bone augmenting material and raising theSchneiderian membrane

FIG. 22 is a sectional view of the sinus after the removal of the hollowbone implant.

FIG. 23 is a perspective view illustrating the novel device used inaccordance with the invention to widen a vessel. In this preferredembodiment the filling element is a catheter and the pouch is in theshape of a double wall sleeve.

FIG. 24 is a perspective view illustrating the novel device used inaccordance with the invention to widen a vessel. In this preferredembodiment the filling element is a catheter and the pouch is in theshape of two connected perpendicular tubes.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

As mentioned further above there are many implementations of theinvention in different tissues and organs. The following descriptionwill focus on embodiments in two fields in order to understand theprinciples of the device and method. The first is bone augmentation inthe jaws and the second is vessel widening using a bioresorbable stent.The same principles should be used in other tissues and organs.

Before turning to the features of the present invention in more detail,it will be useful to clarify certain terminology as will be used hereinin the description and claims. Specifically, it should be noted that thepresent invention is useful in a wide range of applications in whichliving tissue is to be expanded, stretched or displaced. The term“living tissue” is used herein to refer to any living tissue including,but not limited to, an organ, tube, vessel, cavity, or membrane, andinterfaces between any two or more of the above. Where used within asingle type of tissue, the typical application of the present inventionis for expanding the tissue. When used at a tissue interface, theinvention is typically used to displace one of the types of tissue, inmany cases for the purpose of expanding/extending the other tissue. Theinvention may also be used to increase the inner dimensions of tubes,vessels or cavities within the body.

In another matter of terminology there are many types of body canals,blood vessels, ducts, tubes and other body passages, and the term“vessel” is meant to include all such passages. In a further matter ofterminology, it is noted that a large number of different types ofmaterials are known which may be inserted within the body during asurgical procedure and which later dissipate, thereby avoiding the needfor a separate surgical procedure for their removal. Such materials areproperly referred to, depending upon the mechanism by which the materialdissipates, as “bioresorbable”, “bioabsorbabie” or “biodegradable”.Despite the differences between these different classes of materials,the aforementioned terminology is widely used interchangeably by medicalprofessionals. Accordingly, and for conciseness of presentation, onlyone of these terms will generally be used in the following description,without implying the exclusion of the other classes of materials.Additionally, the phrase “bio-dissipative material” is used herein inthe description and claims to refer generically to any and all materialswhich dissipate without requiring surgical removal, independent of whichmechanisms such as dissolution, degradation, absorption and excretiontake place. The actual choice of which type of materials to use mayreadily be made by one ordinarily skilled in the art, and is notgenerally essential to the present invention.

Finally with respect to terminology, reference will be made to abiocompatible filling material used to fill the inflatable elements ofthe present invention. It should be noted that this filling material mayassume a wide range of compositions and consistencies, so long as thebiocompatible material may be forced into the inflatable element. Thus,possible consistencies for the filling material include, but are notlimited to, consistencies described as watery, viscous, gelatinous,moldable, waxen, particulate, and suspensions or mixtures combining anyof the above.

Turning now in detail to the drawings, which depict the presentlypreferred embodiments of the invention for the purpose of illustratingthe practice thereof and not by way of limitation of the scope of theinvention, and in which like reference characters refer to correspondingelements throughout the several views, FIG. 1 illustrates the zygomatic1, alveolar ridge 2, paranasal 3, and submental 4 bone areas on one sideof the face of the skull of a human being. These areas are oftenaugmented.

FIG. 2, illustrates the novel device embodying the present invention foruse in bone reconstruction and, in particular, for augmentation ofatrophic alveolar ridges 2. The device is composed of resorbable pouch5. The pouch can be made from autograft, allograft, xenograft andalloplast and combination thereof. Preferably, pouch is made ofconventionally available polyglycolic acid (PGA) mesh, ahigh-molecular-weight linear polymer made by the ring openingpolymerization of the purified glycolide monomer, although othersuitable materials might be used e.g. polyglactin 910, i.e.polyglycolide co-galactide. In addition, collagen or PDS (anotherabsorbable suture material) or cellulose might possibly also be used asa pouch material. The pouch should be porous towards the bone to allowbone tissue ingrowth and block epithelial tissue ingrowth. The pouchshould be resorbable to prevent a chronic foreign body reaction. Thepouch should not allow the filling material to get out of the pouch andshould stand out pressure.

The pouch 5 is connected to a conduit in the shape of a cannula 6. Theconduit can be also catheter, valve, bone implant, syringe andcombination thereof. Bone implant can be hollow bone implant, slottedbone implant, threaded implant, cylinder implant, smooth surfaceimplant, titanium plasma sprayed implant, hydroxyapatite coated implant,acid etched surface implant, sand blasted surface implant, S.L.A.surface implant, ceramic implant, zirconium implant and any combinationthereof.

The conduit is made of a biocompatible material and can be made frommore then one type of material bioresorbable or non-bioresorbable.Preferably the cannula is made of commercially pure titanium or titaniumalloy used in the dental implant industry. The cannula is connected tothe pouch in one side and in the other side it can be filled and closedwith a screw 7 as a sealing component. Sealing components can be also avalve, a clamping element, a knot and combination thereof. The conduitcan have variable shapes, dimensions, cross section and elasticity Thecannula 6 has preferably fixating components in order to prevent thecannula from moving, get out and cause uncomfortable filling to thepatient. The a fixation component can be selected from the groupconsisting of hook, hole for sutures, slot, thread, bulge, screw, changein dimension, irregularity and any combination thereof.

In this preferred embodiment there are three fixating component. Onefixating component is a slot 8 that is near the pouch and inserted intothe body. After the tissue heals around the slot it prevent the cannulafrom getting out easily. The other two fixating components are holes forsutures 9 that are near the sealing screw 7 and not inserted into thebody. After the insertion of the device the pouch can be filled withbone augmenting material causing the wrinkled and compressed pouch 5 toexpands and become a filled pouch 10 in FIG. 3.

The pouch can be made of more the one type of material. Preferably thepouch is composed of two types of resorbable materials illustrated inFIG. 4. One type that is rapidly resorbed 11 and allows bone ingrowthand the second type 12 that is slowly resorbed and prevent the ingrowthof epithelial tissue. When inserting the pouch the rapidly resorbedmaterial 11 should face the bone.

The slowly resorbed material 12 can be also not resorbable material likeePTFE if in this case the gums are going to be open when placing thedental implants and then the not resorbable material can be taken out.

The pouch can include also self expanding components. Materials include,either alone or in combination, metals or metal alloys, polymers, carbonand ceramics. Exemplary metallic members include stainless steel,titanium, tantalum, shape-memory materials such as nickel-titanium alloy(NiTi) (Compounds using NiTi are manufactured under the marks NITINOL™and ELASTINITE™ and are available from several sources), Elgiloy (tradename) and NP35N (trade designation), which can provide desired degree ofspringiness, malleability and/or response to temperature changes.Exemplary polymers include polyurethanes, silicon rubbers, polyethersulfones, fluoroelastomers, polyimides, polycarbonates, polyethylens,polylactic acid, polyglycolic acid, polyacrylates, and the like andcombinations and copolymers thereof which provide a variety of abilitiesto bioabsorb or biodegrade or to be totally inert. The pouch can includesprings and coils that are compressed before insertion and can includestretchable and elastic materials for example polyurethanes likepolycarbonate urethane.

In another preferred embodiment the pouch can include materials withdifferent degree of stiffness. The material facing the bone can be lessstiff the material facing the gums.

The pouch can have variable shapes and the volumes according to the use.For example to reconstruct the entire jaw the pouch will be elongated inC-shape and filling element will be attached in the middle.

In another preferred embodiment the pouch also includes a selectivebarrier that permits transfer of some cells and materials and preventsthe transfer of other cells and materials. Therefor allowing boneforming cells and blood to get inside the pouch and block the entranceof connective tissue cells. This barrier can also permit the release ofmedication mixed with the filling material without letting the fillingmaterial to leak. This barrier should be adopted for its specific usefor example to have little holes sized according to the medicine to bereleased.

FIG. 5 illustrates a sectional view of the device revealing internalthreads 13 for the sealing screw 7 and another sealing componentpreferably a valve 14 that is open while filling the pouch and is closedotherwise. The chamber 15 between the two sealing components the screw 7and the valve 14 is preferably filled with biocompatible antisepticmaterial like chlorhexedine gel or calcium-hydroxide. The antisepticmaterial should be washed out before filling and put again when thecannula is closed. FIG. 6A illustrates a preferably filling syringe tobe used with the device. The syringe has threads 16 on its tip that machthe internal threads 13 in the cannula used for the screw. The syringeis preferably filled with bone augmenting material 17 in gelatinousconsistency or suspension. The filling material can be an autograft, anallograft, a xenograft, an alloplast, a cytokine, a hormone, a growthfactor, a physiologically acceptable drug, a biological modifier, aprotein, an antigen, a cell chemotaxis stimulator material, a materialinducing osteogenesis, an osteoinduction material, an osteoconductionmaterial, a bioactive material, a bioresorbable material, abioabsorbable material, a biodegradable material and any combinationthereof. The filling material can be augmenting bone material availablein the market like hydroxyapatite, bovine mineral (i.e. Bio-Ossavailable from Geistlich, Swiss), demineralized freezed dried bone,synthetic materials like PLA (i.e. PhisioGraft from Atrix). The fillingmaterial can be also fully or partially not bioresorbable if theprocedure is done only for aesthetic reason and implants are not goingto be inserted, for example crystal hydroxyapetit.

The filling material can include therapeutic materials and can includeself expanding materials from the list mentioned above. Many of the boneaugmenting material has the tendency to expand when getting wet byhydration.

In order to fill the device the screw 7 is screwed out and the syringeis screwed in illustrated in FIG. 6B. While inserting the syringe intothe cannula and screwing the syringe the valve 14 is opened allowing thefilling of the pouch 5 with the filling material 17. When the syringe istaken out the valve is closed preventing the filling material to leakout.

The pouch can be filled directly without a conduit if the pouch has aregion prepared to be perforated by a needle of a syringe and has selfsealing mechanism on removal of the needle as described in U.S. Pat. No.5,695,338 to Robert.

FIG. 7A and FIG. 7B illustrates a side view and a top view of the noveltunnel incision tool. The tool consists of a handle 18 connected to ashank 19. From the surface of the shank 19 a little blade 20 isemerging. There can be more the one blade and the can be arranged indifferent angles. The tool can be made from different types of materialslike stainless steel and to enable replacing of the blades or plasticfor one use only. The shank can be made from elastic materials. Inanother preferred embodiment the height of the blade can be regulated.

The shape size length and surface texture of the handle and the shankand the blade and the angle between them can be changed according to theregion in the mouth. While inserting the shank 19 into a tunnel theblade 20 is making shallow incision to the tissue touching the blade.Because the height of the blade 20 is very small and the blade issurrounded by the surface of the shank, deep incisions and perforationof the tissue is avoided. If the tissue is very thin the use of thetunnel incision tool is not recommended.

The preferred method for using the device of FIG. 2 is illustrated inthe following views. The purpose of the following preferred embodimentis to augment the bone on the buccal and occlusal aspects of thealveolar ridge on the right side of the mandible. FIG. 8A illustrates asmall incision done in the buccal aspect of the alveolar ridge on theright side of the mandible. FIG. 8B illustrates a sectional view of thealveolar ridge showing the atrophic alveolar ridge 50 covered by themucoperiosteal tissue 51. After the incision is done, touching the bone,a small perioseatal elevator is inserted through the incisionsubperioseatally separating the periost from the bone and creating asubperiosteal tunnel. After the tunnel is prepared, the novel tunnelincision tool illustrated in FIG. 7 is inserted and taken out severaltimes in different areas of the tunnel as illustrated in FIG. 9,creating shallow incisions in the periosteum without perforating themucoperisteal tissue. The incisions in the periosteum enable easyexpansion of the mucoperiosteal tissue without large tension. After thetunnel is made a bone file is inserted to the tunnel scratching thecortical bone to cause bleeding in order to induce bone repair cascadeand to take out any granular tissue. After the tunnel and the bone areprepared the novel device illustrated in FIG. 2 is inserted using aninsertion tool 21 through the incision occupying the tunnel asillustrated in FIG. 10. The device is inserted so the part of the pouchthat resorbs first is facing the bone. The slot 8 of the device isinserted into the tunnel and the holes 9 for sutures are left outsidethe tunnel. After the insertion of the device the device is fixate bysutures using the holes 9 for sutures as illustrated in FIG. 11. FIG.11B illustrates a sectional view of the alveolar ridge showing theatrophic alveolar ridge 50 covered by the mucoperiosteal tissue 51 andthe pouch 5 of the device in between. After the device is correctlyplaced and fixate it can be filled. The filling can be done immediatelyafter the insertion or after several days. It is recommended to do someinitial filling immediately after the insertion to verify the correctfunction of the device. FIG. 12A illustrates the filling process, afilling syringe as illustrated in FIGS. 6A and 6B is screwed to thedevice without moving the device and filling the device with boneaugmenting material until some bleaching of the tissue above the pouch 5is seen. It is important not to fill too much in each filling sessionand not to cause too much tension to the tissue. The filling process canbe done once or several times in 2-3 days intervals until the desiredenlargement is reached. FIG. 12B illustrates a sectional view of thealveolar ridge showing the atrophic alveolar ridge 50 covered by themucoperiosteal tissue 51 and the pouch 5 of the device partially filledwith bone augmenting material 17 in between. The mucoperiosteal tissueis expanded. When the time of the resorption of the part of the pouchconnected to the cannula is reached the cannula is taken out and theorifice is closed. The end result is augmented ridge seen in FIG. 13A.FIG. 13B illustrates a sectional view of the new alveolar ridge showingthe previous atrophic alveolar ridge 50 and the new bone 52 covered bythe expanded mucoperiosteal tissue 51. After 6-9 months it is possibleto proceed toward the insertion of dental implants in the augmentedridge.

The foregoing procedure has been described in terms of the mandible. Ofcourse, the same procedure can also be applied to reconstruction of themaxilla and other bones and for other tissues in the body.

For example in another preferred embodiment a similar device can beinserted into the lips or breast filled with material that stimulate fattissue regeneration or connective tissue regeneration resulting inenlargement of these organs.

Another preferred embodiment can use a device that the filling elementfor example the cannula is made of two parts one is external made ofnonresorbable material and the second is internal made of bioresorbablematerial. The border between the two is preferably the slot. In thisdevice it is easy to take the nonresorbable part out by twisting thecannula and leaving the bioresorbable inside the body.

Another preferred embodiment of the device and method is boneaugmentation of the maxillary sinus called also sinus lift. Thisprocedure is done when the alveolar ridge beneath the maxillary sinus istoo short—less then 8 mm height. FIG. 14 illustrates a sectional view ofsuch a sinus 22 near the nasal cavity 23. The floor of the sinus 24 islined with a delicate membrane called the Schneiderian membrane 25.Beneath the floor of the sinus 24 is the short alveolar ridge 26 coveredby the gums 27.

FIG. 15 is illustrating a preferred device appropriate for thispreferred embodiment. The pouch 28 of the device is preferably made ofcollagen and the cannula is preferably a hollow dental implant 29. FIG.16 illustrates a sectional view of the device of FIG. 15. The device haspreferably two sealing components a screw 30 and a valve 31. The pouch28 can be fully or partially packed inside the hollow implant 29.

The preferred method for using the device of FIG. 15 is illustrated inthe following views. The purpose of the following preferred embodimentis to augment the bone above the floor of the sinus 24 and beneath theSchneiderian membrane 25. The first step is drilling using aphisio-dispenser through the alveolar ridge and the gums until touchingthe floor of the sinus as illustrated in FIG. 17. Preferably severaldrills 32 in ascending diameters are to be used as is the technique inthe osteotomy for dental implants. It is also possible to raise a smallmucoperiosteal flap before the drilling. It is also possible to do theosteotomy with osteoms instead of drilling. After the floor of the sinusis reached inserting an osteom 33 through the osteotomy and using amallet 34 to gently brake the floor of the sinus crating a green stickfracture as illustrated in FIG. 18. After the break of the floor, thedevice of FIG. 15 is inserted through the osteotomy and raising theSchneiderian membrane approximately 1 mm as illustrated in FIG. 19. Ifthe hollow implant is a thread implant as the implant of FIG. 15 it isscrewed in place, if the implant is cylindrical it is inserted using themallet. The diameter of the last drill should fit the diameter of theimplant and the length of the implant should fit the height of thealveolar ridge beneath the maxillary sinus. In this preferred embodimentthere is no need for fixating components because the hollow implant isfixated by the bone. After the fixation of the device it can be filledwith bone augmenting material preferably using the syringe illustratedin FIG. 20A and FIG. 20B. The syringe is composed of two parts the body35 and extension 36 of the syringe form one part and the tip of thesyringe 37 is the second part. The tip 37 is screwed on the extension36. After the parts of the syringe are assembled together the syringe isbrought to the hollow implant, taking the screw of the implant out andscrewing the tip 37 into the hollow implant while holding the body ofthe syringe 35. When the tip is screwed inside the hollow implant itopens the valve 31 allowing the bone augmenting material 38 to fill thepouch 28 as illustrated in FIG. 20B. The purpose of this design of thesyringe is to allow access to the posterior part of the maxilla.

While the pouch is filled the Schneiderian membrane is raised asillustrated in FIG. 21. Even if the membrane is torn in the procedure ofinserting the implant or filling the pouch the tear is automaticallyclosed by the pouch material. The end result of the procedure isillustrated in FIG. 22 the alveolar ridge is higher 39 compared to thealveolar ridge before the procedure. The previous floor of the sinus ismarked by the dotted line.

Another preferred embodiment of the device and method is the widening oftubes like fallopian tubes, urethra, intestines, trachea, vessels etc.Without blocking the passage through the tube. The preferred device andmethod for this purpose is illustrated in FIG. 23. In this preferredembodiment the pouch is the shape of double wall sleeve 49. There arelittle cords 50 connecting the inner wall to the outer wall.

In another preferred device illustrated in FIG. 24 the pouch is in theshape of two circular tubes that are connected 40. This configuration isparticularly useful where an intravenous filter function is required.

This pouch is connected to a catheter 41 (filling conduit) made ofbioresorbable material that has a bioresorbable valve 48. The externalpart of the catheter 42 is made of nonresorbable material and has asealing component a screw 43. There is a slot 44 in the catheter 41which is the braking point for taking the catheter out after finishingall the filling of the balloon. The device can be made from differentkinds of bioabsorbable materials. For instance, a polymer from thelinear aliphatic family, such as poly (lactic acid) PLA, poly(glycolicacid) PGA or polycaprolactone, and their associated copolymers, may beemployed polyglactin (PGA-PLA), polydioxanone, polyglyconate (copolymerof trimethilene carbonate and glycolide). Biodegradable polymers such aspolyorthoester, polyanhydride, polydioxanone and polyhydroxybutyrate maybe also employed. By using PLA+PGA as bioresorbable polymer fibers, andby changing the mixing ratio, the half value period for resorption maybe freely controlled within a time period of from weeks to severalmonths. The stiffness of the stent can be controlled as well. It istherefor possible to made the device from several types of materials forexample the outer wall from one type, the inner wall from another typeand the conduit from another material.

The outer surface of the pouch have arrow heads 45 made of a harderbioresorbable material (like PLA) on the external surface forstabilizing the pouch to the walls of the vessel 46 to be widened. Thereare many ways to configure the shape of these stabilizing elements someof them are described in U.S. Pat. Nos. 5,593,434 and 5,423,885 toWilliams. The basic idea is that the outer surface is not flat andsmooth but has holes or protrusions.

Briefly, and in general terms, when the stent is to be deployed in acoronary artery the stent is attached to a catheter prepared for PTCAangioplasty and using a guidewire and tracked by a fluoroscope the stentis percutaneously introduced into the vessel until the stent ispositioned at the desired location.

To facilitate the placement of the stent of the present invention, thestent may be impregnated with a radiopaque material, making it opaque,and therefore visible, to X-rays. Suitable radiopaque materials includeiodine based materials and solutions thereof, and barium salts,including materials containing iodipamide (sold commercially under thetrade name Cholografin) and iopanic acid (sold under the trade nameTelepaque).

After reaching the desired location starting filling the pouch with abiocompatible liquid. When the pouch of FIG. 23 starts to expand itforms a tube. The inner wall of the pouch facing the bloodstream theouter wall facing the walls of the vessel. Between the inner wall an theouter wall of the pouch the filling material is present. The littlecords 50 ensures that the inner wall is connected to the outer wall andnot collapsing to occlude the vessel In this case when the pouch isinflated the vessel is widened and vessel is not occluded. When thepouch of FIG. 24 starts to expand it forms two perpendicular tubes thatare widening the vessel. The joining points of the two tubes arereinforced with a harder bioresorbable material (like PLA) in the shapeof a cross 47. These crosses assure that the two tubes are alignedperpendicular to each other. When the pouch expands it forms twoperpendicular tubes so the vessel is widened bat the vessel is notoccluded because fluid can pass between the perpendicular tubes. Theinflated pouch of FIG. 23 and FIG. 24 is now the stent The pouch can beinflated several times in some days interval if necessary until reachingthe desired widening. It is recommended to widen the vessel more thenfinal desired widening to compensate for future restenosis.

When the stent has been expanded to widen the vessel the stent isaffixed in place by the arrow heads 45 engaging the walls of the artery,including the endothelium layer. It is believed that the endotheliumlayer of the artery will grow into the stent over a short period of time(in 7 to 21 days), to further retain the stent in place. The stenteventually will dissolve and endothelium layer growth into the stent andensures that pieces of the stent will not discharge into the bloodstreamand cause embolism as the stent is dissolved.

After the desired widening is reached the external portion 41, 42 istaken out leaving the bioresorbable device inside the tube. The deviceeventually will be resorbed therefor the chances for chronicinflammation or excess hypertrophy of the vessel are small andconsequently reconstriction of the vessel may be inhibited.

This type of stent is flexible and compliant and crush resistant. Thistype of stent can be very small before inflation therefor can passthrough small vessels without damaging the vessels while insertion andcan adapt itself to the bent shape of the vessel of to furcations.

In another embodiment the filling material can be self expanding. It canexpands by hydration for example. The stent itself can have selfexpanding materials.

In another preferred embodiment of the device and method the stent canbe attached to a catheter with plurality of lumens therein. These lumensterminates in plurality of conduits that open to the outer wall of thestent. This configuration can enable the delivery of bioactive materialslike medications. An example of this idea can be seen in U.S. Pat. No.5,254,089 to Wang.

In a similar embodiment the stent can be made of two tubular balloons.The first one as described for expanding the device and the secondcircumferentially disposed over the first one for delivery ofmedications. The outer wall of the second balloon should have littleholes for the release of the bioactive materials. Each balloon isconnected to a different conduit.

In another preferred embodiment the outer wall of the balloon is made ofselective barrier and filled with at least two materials. The firstmaterial is for expanding the pouch and the second is a bioactivematerial. The expanding material should be biocompatible liquid withhigh molecular weight. The outer wall barrier should enables only therelease of the bioactive materials. The holes in the membrane should fitthe bioactive material. In this embodiment the same conduit allows theexpanding of the pouch and the administration of the bioactivematerials. In this embodiment it is possible to add bioactive materialsfor a long time after the introduction of the stent with no surgicalprocedure.

Bioactive materials can be also incorporated into the material of thepouch or can be impregnated with a therapeutic agent to providelocalized drug delivery, As the pouch is resorbed the material arereleased. Moreover, encapsulating the active agent in a dissolvingmaterial such as albumin or various polymers which would effect acontinuing release of the active agent proximate the irregular wallportion during the patency of the encapsulating agent. Examples of suchpolymers would include pluronics gels, citric acid cycle polymers, suchas polylactic acid polyglycolic acid and derivatives thereof,polyanhydrides, polyphophazenes, polysaccarides, such as alginic acid,chitin and derivatives thereof, collagen and derivatives thereof, andglicosaminoglicans such as hyaluronic acid and derivatives thereof.

In another embodiment the release of bioactive materials can beelectrically monitored or monitored by temperature as described in U.S.Pat. No. 5,857,998 to Barry for treating aneurismal wall.

The bioactive materials for all these embodiments may be selected fromthe group of heparin and derivative thereof, antiplatelet agents such asPPACK, iloprost, integrelin, chimeric antibodies such as c7E3 urokinase,t-PA, hirudin, prostacyclenes and analog thereof, antithrombogenicagents, thrombus lysing agents, steroids, ibuprofen, antimicrobials,antibiotics, tissue plasma activators, rifamicin, monoclonal antibodies,snake venom protein by-products, antifibrosis agents, hyaluronate,cyclosporine, genetic therapies including antisense oligonucleotides andvarious gene constructs, antiproliferatives such as angiopeptin,chemotherapeutic agents such as paolitaxel, antioxidants such asprobucol, vasorelaxants such as nitroglycerin and papverine or ones withmultiple effects such as nitric oxide and mixtures of these bioactivesubstances.

In this preferred embodiment of FIG. 24 there is only one step ofinsertion. It is true that percutaneous transluminal procedures andother procedures involving the insertion of stents into the body haveimproved in recent years. Likewise the reduction in the size of theinstruments inserted into the patient reduces the risk of damage.However, it is still a fact that each insertion and extraction risksfurther damage to afflicted areas and damage to otherwise unaffectedareas through which the instruments pass and can add to patient trauma.Moreover, insertion and withdrawal of additional instruments in sequenceincreases the time of the physician, staff, and medical facility, andthe cost of multiple of multiple instruments.

The device can be used also for the quick closure of a rupture in avessel.

In another embodiment the stent can be modified by heating.

Although the present invention has been described and illustrated in thecontext of certain preferred embodiments, it will be understood thatmodifications may be made without departing from the spirit of theinvention.

1. A method for treating bone within a living body comprising: (a)creating a hole in a periosteal tissue of a bone for insertion of anexpandable portion of a container, said bone having a bone surface, saidbone surface being touched by a covering tissue of said bone, saidcovering tissue is selected from the group consisting of periostealtissue and Schneiderian membrane; (b) prior to inserting said expandableportion of said container, forming a subperiosteal tunnel between saidbone and said periosteal tissue, for insertion of said expandableportion of said container, (c) inserting through said hole between saidbone surface and said covering tissue said expandable portion of saidcontainer, the external surface of said expandable portion of saidcontainer having at least one region which includes at least one openingwhich is open sufficiently to allow penetration of bone tissue and bloodvessels, said expandable portion of said container includes an areawhich is less penetrable to tissue than said region; (d) expanding saidexpandable portion of said container so that said opening is facing saidbone surface and at least part of said area is facing said coveringtissue, said expanding of said expandable portion of said container isdisplacing said area to displace said covering tissue from said bonesurface so the distance between said covering tissue to said bonesurface is increased to allow bone regeneration between said coveringtissue and said bone surface.
 2. The method of claim 1, wherein saidexpanding is performed in a plurality of stages separated by at least anumber of hours, each stage incrementally stretching at least one of theperiosteal tissues of said bone.
 3. The method of claim 1, wherein saidarea of said container includes a guided bone regeneration membranelocated so as to be adjacent to said periosteal tissue.
 4. The method ofclaim 1, wherein said region exhibits a first mean time to dispersionand said area exhibits a second mean time to dispersion longer than saidfirst mean time to dispersion.
 5. The method of claim 1, wherein saidexpandable portion of said container is configured so part of the regionfacing said periosteal tissue is made from a biocompatible metal andanother part of the region facing said periosteal tissue is made from aslowly dissipative bio-dissipative material.
 6. The method of claim 1,further comprising, prior to inserting said expandable portion of saidcontainer peeling said periosteal tissue from said bone.
 7. The methodof claim 1, wherein said periosteal tissue is the mucoperiosteal tissuein the jaws.
 8. The method of claim 1, wherein said expanding is done byintroducing a biocompatible filling material into said container.
 9. Themethod of claim 8, wherein said filling material includes material forpromoting the growth of bone tissue.
 10. The method of claim 8, whereinsaid introducing is performed via a filling conduit partially protrudingoutside the body.
 11. The method of claim 10, wherein said fillingconduit is connected to said container after said inserting into thetissue.
 12. The method of claim 10, wherein said container is insertedinside the body being at least partially inside said filling conduit.13. The method of claim 8, wherein said region is perforated, havingpores which are sufficiently large to allow the ingrowth of bone tissue.14. The method of claim 13, wherein said expandable portion of saidcontainer includes an area which is less penetrable to tissue than saidregion.
 15. The method of claim 14 wherein said area is designed toprevent the filling material from passing through said area.
 16. Themethod of claim 14, wherein said area prevents ingrowth of tissue. 17.The method of claim 14, wherein said area is located at one side of saidexpandable portion of said container and said region is located at theopposite side to said expandable portion of said container.
 18. Themethod of claim 13, wherein said expandable portion of said container isinserted between said bone and said covering tissue so as to increasethe distance between said bone and said covering tissue, said coveringtissue is selected from the group consisting of periosteal tissue andSchneiderian membrane, said expanding is done by introducing abiocompatible material that includes a material that promotes bonetissue regeneration into said container.
 19. The method of claim 13,wherein said container includes a fixation component to preventmovements of said container.
 20. The method of claim 8, furthercomprising, prior to inserting said expandable portion of saidcontainer, forming a path of insertion and a space for said container.21. The method of claim 8, wherein said hole is the only aperture in theperiosteal tissues of said bone through which said container is allowedat least partially to pass through.
 22. The method of claim 8, whereinsaid expandable portion of said container being located between saidbone and said periosteal tissue.
 23. The method of claim 8, wherein saidexpanding is displacing at least part of the Schneiderian membrane sosaid expandable portion of said container being located completely belowsaid part of said displaced Schneiderian membrane and said bone is themaxillary bone.
 24. The method of claim 1, wherein said containerincludes a protruding element designed to protrude through said hole.25. The method of claim 24, wherein said protruding element includes asealing means for sealing said protruding element.
 26. The method ofclaim 24, wherein said protruding element includes a hollow screw. 27.The method of claim 1, wherein said area includes at least onebiocompatible material selected from the group made up of: a metal, ametal alloy, a polymer, a copolymer and ceramics.
 28. The method ofclaim 1, wherein said area is facing the Schneiderian membrane and saidexpanding is displacing said Schneiderian membrane.
 29. The method ofclaim 1, wherein said bone being touched from above by said coveringtissue of said bone and from below being touched by a second coveringtissue of said bone, said expandable portion of said container is beingcompletely below said covering tissue of said bone and at leastpartially above said second covering tissue of said bone and inside thebody for at least several days.
 30. The method of claim 29, wherein saidexpandable portion of said container is configured to have a firstportion which is not perforated and a second portion which isperforated.
 31. The method of claim 29, wherein said container includesmechanical component assisting in the enlargement of said expandableportion of said container.
 32. The method of claim 29, wherein saidcovering tissue is the Schneiderian membrane above said bone and saidsecond covering tissue is part of the periosteal tissue of the upperjaw.
 33. The method of claim 29, wherein said expandable portion of saidcontainer is inserted so at least part of said expandable portion ofsaid container is inside said bone.
 34. The method of claim 29, whereinsaid expandable portion of said container being completely below thedisplaced part of said covering tissue of said bone.
 35. The method ofclaim 1, wherein said expanding is stretching said periosteal tissue.36. The method of claim 1, wherein inserting the majority of saidcontainer through a hole in said bone, said hole in said bone beingsurrounded all around by said bone.
 37. The method of claim 1, furthercomprising, prior to inserting said expandable portion of said containerpeeling said Schneiderian membrane from said bone.
 38. The method ofclaim 36, wherein said expanding is done by introducing a biocompatiblefilling material into said container.
 39. The method of claim 38,wherein said expandable portion of said container is at least partiallylocated in a cavity inside said bone.
 40. The method of claim 39,wherein said cavity has at least one place of non-continuity of the boneat the borders of said cavity.
 41. The method of claim 40, wherein saidexpandable portion of said container includes an area which is lesspenetrable to tissue than said region, said area is facing saidnon-continuity.
 42. The method of claim 41, wherein said area preventsthe leakage of said filling material.
 43. The method of claim 38,wherein said expandable portion of said container is expanded in achamber in the body having hard bone tissue at most of the borders ofsaid chamber and softer tissue inside said chamber.
 44. The method ofclaim 43, wherein said introducing is displacing said softer tissue. 45.The method of claim 38, wherein said expandable portion of saidcontainer is bounded from one side by said bone surface and from anotherside by at least one of the soft tissues that were adjacent to said bonebefore starting the surgical procedure.
 46. The method of claim 45,wherein, said expandable portion of said container includes an areawhich is less penetrable to tissue than said region, said region beingplaced adjacent to said bone surface and said area being placed facingat least part of said soft tissues.
 47. The method of claim 46, whereinsaid region is a perforated region having pores which are sufficientlylarge to allow the ingrowth of bone tissue and said area prevents theleakage of said filling material outside said container.
 48. The methodof claim 38, wherein said filling material includes a first fillingmaterial and a second filling material, said container having pores toallow the release of said second filling material while preventing therelease of said first filling material.
 49. The method of claim 38,wherein said container allows the release of part of said fillingmaterial.
 50. The method of claim 49, wherein said introducing is doneso said part of said filling material is released outside saidcontainer.
 51. The method of claim 50 wherein said container has poresthat are sized according to the filling material to be released.
 52. Themethod of claim 38, wherein said expandable portion of said container isinserted so that the largest diameter of said expandable portion of saidcontainer after being expanded is larger than the largest diameter ofsaid hole in said bone.
 53. The method of claim 1, wherein inserting themajority of said container through a hole in said bone, said hole insaid bone being surrounded substantially all around by said bone. 54.The method of claim 1, wherein said expanding is displacing at least oneof the tissues touching said expandable portion of said container fromsaid bone surface.
 55. The method of claim 1, wherein said hole in saidperiosteal tissue is done using a drill to create a round hole.
 56. Themethod of claim 1, wherein inserting the majority of said containerthrough a hole in said bone, said hole in said bone is done using adrill to create a round hole.
 57. The method of claim 56, wherein saidcontainer includes a filling conduit, the dimension of said hole in saidbone fits the dimension of said filling conduit so said filling conduitis touching said hole in said bone substantially all around the bordersof said hole in said bone.
 58. The method of claim 56, wherein saidexpanding is done by introducing a biocompatible filling material intosaid container through a rigid tube, said tube fits the size of saidhole in said bone.
 59. The method of claim 1, wherein said hole beingsurrounded all around by said periosteal tissue.
 60. The method of claim1, wherein said expandable portion of said container includes an areawhich prevents ingrowth of tissue and said region is perforated, havingpores which are sufficiently large to allow the ingrowth of bone tissue.61. The method of claim 1, wherein said covering tissue is theperiosteal tissue covering the external surface of said bone.
 62. Themethod of claim 61, wherein said expandable portion of said containerincludes an area which prevents ingrowth of epithelial tissue and saidregion is perforated, having pores which are sufficiently large to allowthe ingrowth of bone tissue.
 63. The method of claim 62, wherein atleast part of said expanding is done by introducing a bone growthinducing material into said container.
 64. The method of claim 62,wherein said bone is the alveolar ridge and said periosteal tissue isdisplaced towards the oral cavity.
 65. The method of claim 64, whereinat least part of said area is made from a guided bone regenerationmembrane and said guided bone regeneration membrane is facing saidperiosteal tissue.
 66. The method of claim 65, wherein at least part ofsaid expanding is done by introducing a bone growth inducing materialinto said container.
 67. The method of claim 61, wherein at least partsaid expanding is done by introducing a bone growth inducing materialinto said container.
 68. The method of claim 61, wherein said bone isthe alveolar ridge and said periosteal tissue is displaced towards theoral cavity.
 69. The method of claim 38, wherein said filling materialis a bone filler.
 70. The method of claim 1, wherein said coveringtissue is the Schneiderian membrane and at least part of said area ismade from a guided bone regeneration membrane.